In 6 years, US FDA rejected 13,000 Indian products

As many as 13,334 products made in India were rejected by the US Food and Drug Administration (FDA) between 2010 and 2015, FDA data shows. During the period, it rejected imports of 15,087 Chinese products.February 09, 2016, 13:29 IST

Bengaluru: As many as 13,334 products made in India were rejected by the US Food and Drug Administration (FDA) between 2010 and 2015, FDA data shows. During the period, it rejected imports of 15,087 Chinese products.

According to the ministry of commerce and industry, the rejected products include patent medicines, generic medicines, snacks, bakery products, spices (ground, mixed) and seasonings, bath soaps and detergents. And, the reasons include problems in packaging, misbranding, contamination, high residue levels and labelling.

In January 2016, India saw 228 rejections - China saw 314 - pointing to another year of huge rejections at a time when the Centre has been advancing the 'Make-in-India' agenda. On January 5, 2016, three drugs from Intas Pharmaceutical Limited (1) and Sanofi India Limited (2), were rejected as they were unapproved drugs under sections "505(a), 801(a)(3)" of the FDA rules.

When asked to comment about the rejections, Biocon CMD Kiran Mazumdar-Shaw said: "I cannot comment on specific cases. But, there is a problem, ranging from data integrity issues where some of our firms have been caught fudging data red-handed, to issues with clean environments - there was a case where a sterile area had a leaky roof - which is unacceptable and so on."

Shaw added: "Just look at the warning letters issued to our firms, I won't name... but they are in detail. And not arbitrary."

On January 6, two items exported by Andhra Pradesh's RDR Export were rejected by the US FDA citing adulteration. "The article appears to bear or contain a food additive, namely nitrofurans, that is unsafe," the FDA says regarding one of the items.

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